The risk of bleeding with Pradaxa is not as prevalent as it was seven years ago when it was released, now that the new generation anticoagulant has its own reversal agent.

The bleeding antidote, Praxbind, helps mitigate the risk of bleeding with Pradaxa by counteracting uncontrollable bleeding injuries that may occur. It is important to note that Praxbind is available at hospitals, where it can be implemented in emergency situations.

But even with the release of Praxbind in 2015, the risk of bleeding with Pradaxa is still significant amongst patients who were prescribed the drug. This is because the anticoagulant treatment mechanism involves inhibiting the body’s clotting ability and increases efficiency in blood flow overall.

Pradaxa and other anticoagulants are often prescribed to patients suffering from atrial fibrillation who are at high risk for stroke, as anticoagulants are used to prevent blood clots from forming. However the treatment mechanisms also prevents the body from healing itself from minor internal bleeding incidents, often resulting in emergency room visits.

Before Praxbind was approved, warfarin was the only anticoagulant with a widely available reversal agent in the form of vitamin K. Before the release of Pradaxa and the new generation anticoagulants, warfarin was the primary choice for anticoagulant treatment for patients. Pradaxa, Xarelto and other anticoagulants released later directly compete against each other and warfarin.

Pradaxa was approved by the FDA in 2010, and quickly overtook warfarin in popularity after Borheinger Ingelheim focused its marketing on the drug’s convenience. In contrast to warfarin, Pradaxa could be prescribed in a single dose and did not require frequent doctor visits for dose adjustments.

However the risk of bleeding with Pradaxa quickly became apparent, after numerous injury reports indicated internal bleeding injuries.

Overview of Pradaxa Internal Bleeding Complications

The risk of bleeding with Pradaxa is still seen in the numerous injury reports filed by patients who had allegedly experienced the complications first hand. Patients who experience Pradaxa internal bleeding complications should seek medical attention immediately, and be vigilant for unusual symptoms including:

• Unusual Bleeding or Bruising
• Pink or Brown Urine
• Red or Black Tarry Stool
• Coughing up Blood
• Vomit looks like Coffee Grinds
• Fatigue
• Gums Bleeding
• Frequent Nose Bleeds
• Weakness and Swelling in Arms, Hands, Feet, Ankles, or Lower Legs

The risk of bleeding with Pradaxa is most significant in older patients with kidney problems, as the drug is directly processed through the kidneys. The risk of gastrointestinal bleeding may be higher in patients who are taking additional drugs with links to internal bleeding, like non-steroidal anti-inflammatory drugs (NSAIDs) or other blood thinners.

According to the recent SAVOR studies, there are significant bleeding risks associated with Pradaxa. Researchers found that:

• 16.6% of patients may experience Pradaxa internal bleeding
• 3.3% of patients may experiences serious Pradaxa bleeding
• 1.5% of patients may experience life threatening Pradaxa bleeding
• 0.3% of patients may experience brain hemorrhage Pradaxa bleeding

The FDA warned against the risk of bleeding with Pradaxa in 2011, alerting the public and medical community to the risk of uncontrollable Pradaxa bleeding seen in post market studies. Patients who have experienced Pradxa internal bleeding may be able to file legal action for compensation.